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Acute Hyperbaric Oxygen (HBO) Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04219215
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center

Brief Summary:
Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. To study the underlying mechanisms, we want to examin the short-term effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ROS) in a randomized, double blinded, placebo-controlled cross-over trial.

Condition or disease Intervention/treatment Phase
Type 2-diabetes Device: hyperbaric oxygen chamber Not Applicable

Detailed Description:

In total 14 patients are planned. Each participant participates in both experimental parts (100% O2 and ambient air). They are examined immediately after each HBO/ ambient air therapy. The allocation is randomized treated every three weeks with 2-hour therapies using pure O2 or indoor air. Randomized and double-blinded in a cross-over setting, one group of patients with type 2 diabetes is first treated with HBO therapy and the other group is first treated with room air. Here, an ambient pressure of 2.4 ATM is built up and then administered for respiration over a total of 90 minutes of pure O2. Patients are examined on two consecutive days for each part of the study.On the first day serum samples are taken and a sample is taken from the vastus lateralis muscle. A magnetic resonance spectroscopic examination (MRS) is performed on the patient subsequently. In this case, phosphorus metabolites (absolute quantification of ATP, Pi) and the ATP synthase flow rate (fATP) are determined non-invasively by means of 31P MRS and TG storage (HCL) by means of 1H-MRS.

On the next day of the trial patients are treated with HBO therapy or room air. A hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated glucose (D- [6,6-2H2] glucose) (0-120 min) to measure muscular and hepatic insulin resistance will be performed after the end of HBO therapy or room air treatment performed. Indirect calorimetry determines energy consumption and substrate selection (lipid and glucose oxidation) in hyperinsulinaemia. After the end of the HBO therapy or room air treatment and 30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis muscle again.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Hyperbaric Oxygen (HBO) Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in Type 2 Diabetes
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBO
Patients with T2D receive an 2 hour treatment with 100 % oxygen in a hyperbaric chamber
Device: hyperbaric oxygen chamber
Application of 100% O2 in an hyperbaric oxygen chamber

Device: hyperbaric oxygen chamber
Application of ambient air (21% O2) in an hyperbaric oxygen chamber

Experimental: Ambient Air
Patients with T2D receive an 2 hour treatment with 21% oxygen in a hyperbaric chamber
Device: hyperbaric oxygen chamber
Application of 100% O2 in an hyperbaric oxygen chamber

Device: hyperbaric oxygen chamber
Application of ambient air (21% O2) in an hyperbaric oxygen chamber




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤ 75 years
  • Type 2 diabetes
  • HbA1c ≥ 6 and ≤ 9%
  • BMI ≤ 35 kg / m2

Exclusion Criteria:

  • Treatment with thiazolidinedione in the last 6 months
  • Uncontrolled hyperglycemia (FPG ≥ 240 mg / dl)
  • vitamin supplement (washing out at least 4 weeks)
  • Patients requiring revascularization
  • Serum CRP ≥ 5 mg / dl
  • Previous treatment for HBO therapy
  • Secondary diabets according to ADA criteria (type 3 B-H, eg pancreopriver diabetes)
  • Type 4 diabetes (gestational diabetes), pregnancy
  • poor glycemic control (HbA1c> 9.0%)
  • Hyperlipidemia (low density triglycerides and lipoproteins ≥ double upper Reference limit)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219215


Locations
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Germany
German Diabetes Center Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Evrim Anadol, MD    0211-33-82-699    evrim.anadol@ddz.uni-duesseldorf.de   
Sponsors and Collaborators
German Diabetes Center

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Responsible Party: julia szendrödi, Principal Investigator, PD Dr. med., German Diabetes Center
ClinicalTrials.gov Identifier: NCT04219215    
Other Study ID Numbers: HBO
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs